Human Milk Concentration for Premature Infants
(NEOMOM Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new device, the Human Milk Concentration Device, to determine if it can safely concentrate nutrients in breast milk for preterm infants. The goal is to assess whether babies fed this nutrient-rich milk grow and remain healthy as well as those receiving regular fortified milk. Researchers will examine how well babies tolerate the feeding, their weight gain, and the associated costs. Babies born between 32 and 34 weeks who are already being fed their mother's milk might be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance nutrition for preterm infants.
What prior data suggests that this human milk concentration device is safe for preterm infants?
Research shows that using a device to concentrate nutrients in human milk for premature babies is likely safe. This device increases the nutrient content of human milk without adding cow's milk-based supplements. This is important because studies have found that cow's milk-based supplements can lead to more health problems in premature babies. Using this device avoids the risks linked to cow's milk additives.
Human milk helps premature babies grow and stay healthy. Research indicates that a diet made entirely of human milk can reduce the need for other feeding methods and support better growth and development over time.
While specific data on the exact safety of this device is lacking, using only human milk is generally seen as beneficial for premature babies. This suggests that the human milk concentration device is safe and potentially advantageous.12345Why are researchers excited about this trial?
Unlike standard treatments for premature infants, which often involve supplementing mother's milk with cow's milk-based fortifiers or formula, the Human Milk Concentration (HMC) device offers a unique approach. It concentrates the mother's own milk, boosting its nutrient density without adding any bovine-derived products. This method preserves the natural properties and benefits of human milk while potentially providing the additional nutrients that preterm infants need to thrive. Researchers are excited about this treatment because it could enhance infant nutrition and development while minimizing exposure to non-human milk components.
What evidence suggests that this human milk concentration device is effective for premature infants?
Research has shown that using a device to concentrate human milk can benefit premature babies. In this trial, one group of preterm infants will receive enteral feedings of their mother's own milk (MOM) concentrated with the human milk concentration device, which boosts nutrient density without bovine-derived fortifiers. Studies have found that this method can enhance brain and vision development and strengthen the immune system. Evidence indicates that concentrated MOM aids preterm babies' growth by increasing milk nutrients without cow's milk-based supplements. This approach may also reduce the risk of bronchopulmonary dysplasia in these infants. Overall, the human milk concentration device presents a promising alternative to standard cow's milk-based supplements, which will be used in the comparator group of this trial.16789
Who Is on the Research Team?
Sarah Taylor, MD
Principal Investigator
Yale University
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Preterm infants receive enteral feedings of mother's own milk, either concentrated using the HMC device or supplemented with cow's milk-based fortifier or formula.
Follow-up
Participants are monitored for growth velocity, serum phosphate levels, and overall clinical stability.
Resource Utilization Assessment
Evaluation of cost and resource utilization associated with feeding strategies, including preparation time, supply costs, and total NICU cost of care.
What Are the Treatments Tested in This Trial?
Interventions
- Human Milk Concentration Device
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Preterm infants receive enteral feedings of mother's own milk that has been concentrated using the HMC device to increase nutrient density without the addition of bovine-derived fortifiers.
Preterm infants receive enteral feedings of mother's own milk supplemented with cow's milk-based fortifier or formula according to institutional standard of care.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mother's Milk is Best
Lead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Beth Israel Deaconess Medical Center
Collaborator
Weill Medical College of Cornell University
Collaborator
Yale University
Collaborator
Citations
Comparison of the short-term neonatal outcomes of preterm ...
This study aims to compare the short-term outcomes of preterm neonates pre- and post-launch of human milk bank in Iran.
A Systematic Review on the Impact of Donor ...
We found substantial evidence gaps in understanding how DHM treatments influence health and growth in premature infants. Research prioritizing ...
Concentrating Human Milk: An innovative point-of-care device ...
The purpose of this study was to determine whether a point-of-care osmotic device concentrates important human milk (HM) nutrients to support feeding neonates ...
Point-of-care human milk concentration by passive osmosis
Feeding preterm infants, MOM improves brain, vision, microbiome, and immune system development and reduces the incidence of bronchopulmonary ...
Early Routine vs. Selective Human Milk Fortification in ...
Infants in the SF group will have human milk increased to 180 mL/kg/day (120 kcal/kg/day) and maintained at this volume unless fortification is ...
Human milk-based fortifiers cut mortality rate by 50% in ...
“The data associates bovine (cow) milk-based fortifiers with a potentially increased risk of death in preterm infants, which makes a reversal possibly necessary ...
Evidence summary of human milk fortifier in preterm infants
This study summarized the best evidence for human milk fortifier in preterm infants. Medical staff should assess the specific clinical conditions and parental ...
MMIB – Helping premature babies survive to thrive
Revolutionizing preterm infant feeding with our human milk concentration device that allows for optimized use of human milk in four easy steps.
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prnewswire.com
prnewswire.com/news-releases/human-milk-based-fortifiers-cut-mortality-rate-by-50-in-preterm-infants-independent-study-shows-302180944.htmlHuman Milk-Based Fortifiers Cut Mortality Rate by 50% in ...
PRNewswire/ -- An independent study published in the journal Nutrients found a 50% reduction in mortality among preterm infants fed human ...
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